Wound HealNCT04805463
Different Platelet Concentrates After Gingivectomy and Gingivoplasty Evaluation of Its Effect on Early Wound Healing.
A study testing PRF group, CGF group and AFG group in people with Wound Heal and Gingival Overgrowth, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the effect of PRF, CGF and AFG application on early wound healing after gingivectomy and gingivoplasty operations. In the study designed split mouth, gingivectomy and gingivoplasty surgery were performed on 19 patients. Read more about this study
- Who is it for?
- Ages 12 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Heal, Gingival Overgrowth, Gingival Enlargement
- What is being tested?
- PRF group, CGF group and AFG group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients who are systemically healthy, have chronic inflammatory gingival enlargement in the maxillary and mandibular anterior region, and who do not have attachments and bone loss in clinical and radiographic evaluation.
Who cannot join
- Patients with a history of periodontal treatment in the last 6 months, smokers, those using drugs that may cause gingival enlargement, and pregnant or breastfeeding women were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Periodontology, Faculty of Dentistry, Inonu University
Malatya, Battalgazi, 44280
About this study
Official title: Evaluation of the Effects of PRF, CGF and AFG Application on Wound Healing Following Gingivectomy and Gingivoplasty Operations: a Randomized Controlled Clinical Trial
The aim of this study was to evaluate the effect of PRF, CGF and AFG application on early wound healing after gingivectomy and gingivoplasty operations. In the study designed split mouth, gingivectomy and gingivoplasty surgery were performed on 19 patients. The postoperative PRF, CGF, and AFG applied areas were compared with the control regions. 0th,7 th,14 th and 28 th on the days, the surgical area was painted with mira-2-tone solution and evaluated in the ImageJ program. Measurements of clinical periodontal parameters including PI, GI, SC and SD were recorded at the beginning, after IPT and 28 days after the operation. Wound healing was evaluated with H2O2 test, VAS-Pain, and LTH index on 7th, 14th and 28th days. The patients were asked to evaluate their aesthetic perceptions on the VAS aesthetic scale.
Read the detailed description
Study design and patient selection
In this randomized, controlled, split-mouth (lower, upper jaw, right and left anterior regions) clinical study, who applied to İnönü University Faculty of Dentistry Department of Periodontology between January 2020 and May 2020, due to gingival problems, chronic examination was performed. included individuals diagnosed with inflammatory gingival enlargement.
All patients received initial periodontal therapy (BPT). The patients were called for control after 2 weeks and surgery was planned for the patients who provided adequate oral hygiene. In our study, the vertical DM index, first described by Goaz and Angelopoulos, and later modified by Damm and Miller (DM), was used to classify the gingival enlargement in the vertical direction (1). In order to classify the bucco-lingual gingival growths in the interdental papillae, the horizontal MB index, first described by Seymour et al. And later modified by Miranda and Brunet (MB), was used (2). As a result of the measurements made, grades other than score 0 according to the DB and MB indices were accepted as having gingival enlargement. The distribution of control (n = 19) and three test groups (n = 19, n = 19, n = 19) after gingivectomy and gingivoplasty was randomized (block randomization).
Clinical Measurements
In clinical periodontal evaluation, plaque index (PI) (3), gingival index (GI) (4), bleeding on probing (SC) and probing depth (SD ) measurements were performed at baseline (T0), after BPT (T1) and on the 28th day (T2) after gingivectomy and gingivoplasty operation. Measurements were made in a total of 6 regions of all teeth: mesio-buccal, mid-buccal, disto-buccal, disto-lingual / palatinal, mid-lingual / palatinal and mesio-lingual / palatinal. Clinical periodontal measurements of all teeth of the individuals included in the study were performed by a single investigator (E.B.).
Gingivectomy and gingivoplasty
Before surgery, all patients were gargled with 0.12% chlorhexidine for 1 minute. The incision lines were determined by applying infiltrative anesthesia (Maxicaine Fort) to the areas to be operated, and the external bevel incision was performed with a # 15 scalpel (Broche® Medical scalpel tip; carbon steel) and a Kirkland blade (Hu-Friedy, Chicago, IL, USA). Orban blade (Hu-Friedy, Chicago, IL, USA) was used in the interproximal areas. After the incision was completed, the remaining gum pieces were removed with the help of periodontal curette and microsurgical scissors (Hu-Friedy, Chicago, IL, USA). Then gingivoplasty was performed. After gingivectomy and gingivoplasty, the control areas were left to recover spontaneously. PRF, CGF and AFG were applied to the test areas. Surgical areas in control and test areas were covered with a periodontal pat (Coe-Pak, lsip, IL, USA).
Preparation of platelet-rich fibrin membrane
Blood taken from the antecubital veins of the patients was collected into 10 ml sterile glass-covered plastic tubes (Vacuette serum tubes, Greiner Bio-one) that did not contain anticoagulants. The collected venous blood was placed in the PC-02 (Process, Nice, France) centrifuge device and centrifuged at 3000 rpm for 10 (400xg) minutes (5). The obtained PRF was taken out of the tube, placed in the PRF-BOX and turned into a membrane by compressing with light pressure for about 1 minute. The prepared PRF membranes were applied to the surgical operation area and the operation area was closed with a periodontal pat.
Preparation of concentrated growth factor membrane
Blood taken from the antecubital veins of the patients was collected into 10 ml sterile glass-covered plastic tubes (Vacuette serum tubes, Greiner Bio-one) that did not contain anticoagulants. These tubes were then centrifuged in a centrifuge device (Medifuge; Silfradent srl, Sofia, Italy) using a program with the following features: acceleration for 30 seconds followed by 2 minutes (692xg) at 2700 rpm, 4 minutes (547xg) at 2400 rpm, 2700 rpm. Centrifugation for 4 minutes (592xg) at 3000 rpm for 3 minutes (855xg) and finally deceleration for 36 seconds (6). After centrifugation, CGF was taken from the middle part of the tube, placed in PRF-BOX and turned into a membrane by compressing with light pressure for about 1 minute. Prepared CGF membranes were applied to the surgical operation area and the operation area was closed with a periodontal pat.
Preparation of autologous fibrin glue
Venous blood taken from the patient was transferred to a 9 ml glass-covered plastic tube (Vacuette serum tubes, Greiner Bio-one) that did not contain any anticoagulants. Sohn et al. In the protocol he recommended (7), the venous blood collected in the tube was centrifuged in a centrifuge device (Medifuge, Silfradent, Italy) at 2700 rpm (approximately 692 g) for 2 min. AFG obtained from the upper part of the tube after centrifugation was collected with the help of an injector and transferred to the metal body. The polymerization was allowed for 15-20 minutes. After polymerization was completed, AFG was applied to the surgical operation area and the operation area was covered with a periodontal pat.
Post Operative Care and Suggestion
Patients were advised to protect the wound area with periodontal pats from trauma, not to consume too hot and too cold foods, and to eat soft foods. It was stated that the pat should be kept in the mouth for 1 week, and if the pat was damaged during this period, they should apply to our clinic immediately. Patients were prescribed paracetamol-containing analgesic (Parol 500 mg) and a mouthwash containing 0.12% chlorhexidine to use three times a day for a week. The patients were only advised not to brush their teeth in the operation area for 1 week. It was stated that he should provide oral hygiene in areas that were not operated. They were advised to use an extra soft toothbrush in the area after the pat was removed.
Surface area determination
Mira-2-tone, a plaque staining agent (GMBH \& Co., Duisburg, Germany), was used to detect wound surface epithelization at baseline, postoperative 7, 14, and 28 days. Standardized photographs were taken from each patient to evaluate the dark stained areas after staining with Mira-2-tone in the gingiva where epithelialization was not completed and wound healing continued. During the photo shoot, the patients were seated upright and facing straight ahead. All photos were taken by a single person on the same camera (Nikon Coolpix 4500, Tokyo, Japan), at the same distance (20 cm) and light values (ISO-800). The photo size was scaled by using a 10 mm Williams periodontal probe during the photo taking. Wound surface epithelization was calculated using Image J software program (National Institutes of Health, USA ImageJ 1.48V) from the photographs obtained. Each measurement step was done by the same researcher (E.B.) each time. The calibration of the person who made the measurements was performed by repeating the wound surface epithelialization area measurement at one-week intervals on the photo images of 10 patients who had undergone gingivectomy and gingivoplasty surgery and were not included in the study. In these two separate evaluations, the calculations were 95% compatible.
Epithelialization test
In order to evaluate the wound surface epithelization during the healing process, 3% H2O2 was applied to the surface of the operation area with the help of an injector. As a result of the decomposition of H2O2 into water and oxygen through the catalase enzyme released by the blood cells present in the wound area, it was evaluated as "epithelization incomplete" if foaming was observed with oxygen formation, and "epithelization completed" if foaming was not observed . H2O2 test was performed at the controls on the 7th, 14th and 28th days after the operation.
Healing index Landry, Turnbull, and Howley (LTH) index, which classified the healing process according to wound surface redness, presence of bleeding, granulation tissue, epithelization, and suppuration (8). The wound healing process with LTH index was performed at the postoperative 7th, 14th and 28th days.
Postoperative pain and aesthetic
VAS was used for postoperative pain and aesthetic evaluation (9). The patient's 7th, 14th He was asked to evaluate the level of pain he felt from 1 to 10 according to the VAS-Pain (1: low pain, 10: severe pain) scale in the control sessions on the 28th and 28th days. In the control session on the 28th day, the patients were asked to evaluate their aesthetic perceptions from 1 to 10 according to the VAS-Aesthetics (1: dissatisfied, 10: very satisfied) scale.
- Being tested
- Control group, PRF group, CGF group, AFG group
- Keywords
- Autologous fibrin glue, Concentrated growth factor, Gingivectomy, Gingivoplasty, Platelet rich fibrin
- Medical subject headings
- Gingival Overgrowth, Gingival Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupOther
The group that did not undergo any procedure after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA) was applied to the wound area.
PRF groupOther
The group in which PRF is applied to the wound area after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA)was applied over the PRF.
CGF groupOther
The group in which CGF is applied to the wound area after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA) was applied over the CGF.
AFG groupOther
The group in which AFG is applied to the wound area after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA) was applied over the AFG.
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | After gingivectomy and released into the secondary wound healing gingivoplasty group. Receives: Other: Control group |
| PRF group | Experimental | The group in which PRF was applied to the wound surface after gingivectomy and gingivoplasty. Receives: Other: PRF group |
| CGF group | Experimental | The group in which CGF was applied to the wound surface after gingivectomy and gingivoplasty. Receives: Other: CGF group |
| AFG group | Experimental | The group in which AFG was applied to the wound surface after gingivectomy and gingivoplasty. Receives: Other: AFG group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of non-epithelialized areas on the wound surface
Mira-2 tone solution was used to identify non-epithelialized areas on wound surfaces after gingivectomy and gingivoplasty. Mira-2 tone was applied to the wound surfaces and dark dyed areas were calculated as mm2 in Image j program.
Measured: Postoperative 0, 7, 14 and 28 days, the change of the stained area with the mira-2 tone in the wound surface area was recorded.
Epithelialization test
H2O2 was used to identify non-epithelialized areas. If bubbling is observed after the application of H202 to the wound surface, epithelialization was incomplete, if bubbling was not observed, epithelialization was recorded as completed.
Measured: The change in wound surface epithelization was evaluated on the 7th, 14th and 28th days postoperatively.
Healing index
Landry, Turnbull, Howley (LTH) index, which classified the healing process according to wound surface redness, presence of bleeding, granulation tissue, epithelization, and suppuration, was evaluated.
Measured: Wound healing evaluation with LTH index was performed at the postoperative 7th, 14th and 28th day controls.
Postoperative pain
VAS was used for postoperative pain assessment. The patients were asked to evaluate the level of pain from 1 to 10 according to the VAS-Pain (1: low pain, 10: severe pain) scale during the control sessions.
Measured: Evaluation of VAS-Pain change on postoperative 7th, 14th and 28th days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start1 Jan 2020
- Primary completion30 Apr 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Wound HealStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split mouth design was used in the study. The chin was divided into lower, upper and right, and left anterior regions. The distribution of the platelet concentrate and control group to be used after gingivectomy and gingivoplasty was randomly decided.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Bozkurt, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805463
- Sponsor's protocol ID
- 2019/216
- Status last verified
- Mar 2021
- First submitted
- 16 Mar 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have other studies using this data.
Publications
Miranda J, Brunet L, Roset P, Berini L, Farre M, Mendieta C. Prevalence and risk of gingival enlargement in patients treated with nifedipine. J Periodontol. 2001 May;72(5):605-11. doi: 10.1902/jop.2001.72.5.605.
PubMed 11394395SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.
PubMed 14158464LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
PubMed 14121956Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part II: platelet-related biologic features. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e45-50. doi: 10.1016/j.tripleo.2005.07.009. Epub 2006 Jan 10.
PubMed 16504850Rodella LF, Favero G, Boninsegna R, Buffoli B, Labanca M, Scari G, Sacco L, Batani T, Rezzani R. Growth factors, CD34 positive cells, and fibrin network analysis in concentrated growth factors fraction. Microsc Res Tech. 2011 Aug;74(8):772-7. doi: 10.1002/jemt.20968.
PubMed 21780251Sohn D-S, Huang B, Kim J, Park WE, Park CC. Utilization of autologous concentrated growth factors (CGF) enriched bone graft matrix (Sticky bone) and CGF-enriched fibrin membrane in Implant Dentistry. J Implant Adv Clin Dent. 2015;7:11-29.
Landry RG. Effectiveness of Benzydamine HC1 in the Treatment of Periodontal Post-surgical Patients: Faculty of Dentistry, University of Toronto; 1985.
Crichton N. Visual analogue scale (VAS). J Clin Nurs. 2001;10(5):706-6
Miller CS, Damm DD. Incidence of verapamil-induced gingival hyperplasia in a dental population. J Periodontol. 1992 May;63(5):453-6. doi: 10.1902/jop.1992.63.5.453.
PubMed 1527689
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of PRF, CGF and AFG Application on Wound Healing Following Gingivectomy and Gingivoplasty Operations: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04805463
- Acronym / sponsor ID
- 2019/216
- Keywords
- Autologous fibrin glue, Concentrated growth factor, Gingivectomy, Gingivoplasty, Platelet rich fibrin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to evaluate the effect of PRF, CGF and AFG application on early wound healing after gingivectomy and gingivoplasty operations. In the study designed split mouth, gingivectomy and gingivoplasty surgery were performed on 19 patients. The postoperative PRF, CGF, and AFG applied areas were compared with the control regions. 0th,7 th,14 th and 28 th on the days, the surgical area was painted with mira-2-tone solution and evaluated in the ImageJ program. Measurements of clinical periodontal parameters including PI, GI, SC and SD were recorded at the beginning, after IPT and 28 days after the operation. Wound healing was evaluated with H2O2 test, VAS-Pain, and LTH index on 7th, 14th and 28th days. The patients were asked to evaluate their aesthetic perceptions on the VAS aesthetic scale.
Detailed description
Study design and patient selection
In this randomized, controlled, split-mouth (lower, upper jaw, right and left anterior regions) clinical study, who applied to İnönü University Faculty of Dentistry Department of Periodontology between January 2020 and May 2020, due to gingival problems, chronic examination was performed. included individuals diagnosed with inflammatory gingival enlargement.
All patients received initial periodontal therapy (BPT). The patients were called for control after 2 weeks and surgery was planned for the patients who provided adequate oral hygiene. In our study, the vertical DM index, first described by Goaz and Angelopoulos, and later modified by Damm and Miller (DM), was used to classify the gingival enlargement in the vertical direction (1). In order to classify the bucco-lingual gingival growths in the interdental papillae, the horizontal MB index, first described by Seymour et al. And later modified by Miranda and Brunet (MB), was used (2). As a result of the measurements made, grades other than score 0 according to the DB and MB indices were accepted as having gingival enlargement. The distribution of control (n = 19) and three test groups (n = 19, n = 19, n = 19) after gingivectomy and gingivoplasty was randomized (block randomization).
Clinical Measurements
In clinical periodontal evaluation, plaque index (PI) (3), gingival index (GI) (4), bleeding on probing (SC) and probing depth (SD ) measurements were performed at baseline (T0), after BPT (T1) and on the 28th day (T2) after gingivectomy and gingivoplasty operation. Measurements were made in a total of 6 regions of all teeth: mesio-buccal, mid-buccal, disto-buccal, disto-lingual / palatinal, mid-lingual / palatinal and mesio-lingual / palatinal. Clinical periodontal measurements of all teeth of the individuals included in the study were performed by a single investigator (E.B.).
Gingivectomy and gingivoplasty
Before surgery, all patients were gargled with 0.12% chlorhexidine for 1 minute. The incision lines were determined by applying infiltrative anesthesia (Maxicaine Fort) to the areas to be operated, and the external bevel incision was performed with a # 15 scalpel (Broche® Medical scalpel tip; carbon steel) and a Kirkland blade (Hu-Friedy, Chicago, IL, USA). Orban blade (Hu-Friedy, Chicago, IL, USA) was used in the interproximal areas. After the incision was completed, the remaining gum pieces were removed with the help of periodontal curette and microsurgical scissors (Hu-Friedy, Chicago, IL, USA). Then gingivoplasty was performed. After gingivectomy and gingivoplasty, the control areas were left to recover spontaneously. PRF, CGF and AFG were applied to the test areas. Surgical areas in control and test areas were covered with a periodontal pat (Coe-Pak, lsip, IL, USA).
Preparation of platelet-rich fibrin membrane
Blood taken from the antecubital veins of the patients was collected into 10 ml sterile glass-covered plastic tubes (Vacuette serum tubes, Greiner Bio-one) that did not contain anticoagulants. The collected venous blood was placed in the PC-02 (Process, Nice, France) centrifuge device and centrifuged at 3000 rpm for 10 (400xg) minutes (5). The obtained PRF was taken out of the tube, placed in the PRF-BOX and turned into a membrane by compressing with light pressure for about 1 minute. The prepared PRF membranes were applied to the surgical operation area and the operation area was closed with a periodontal pat.
Preparation of concentrated growth factor membrane
Blood taken from the antecubital veins of the patients was collected into 10 ml sterile glass-covered plastic tubes (Vacuette serum tubes, Greiner Bio-one) that did not contain anticoagulants. These tubes were then centrifuged in a centrifuge device (Medifuge; Silfradent srl, Sofia, Italy) using a program with the following features: acceleration for 30 seconds followed by 2 minutes (692xg) at 2700 rpm, 4 minutes (547xg) at 2400 rpm, 2700 rpm. Centrifugation for 4 minutes (592xg) at 3000 rpm for 3 minutes (855xg) and finally deceleration for 36 seconds (6). After centrifugation, CGF was taken from the middle part of the tube, placed in PRF-BOX and turned into a membrane by compressing with light pressure for about 1 minute. Prepared CGF membranes were applied to the surgical operation area and the operation area was closed with a periodontal pat.
Preparation of autologous fibrin glue
Venous blood taken from the patient was transferred to a 9 ml glass-covered plastic tube (Vacuette serum tubes, Greiner Bio-one) that did not contain any anticoagulants. Sohn et al. In the protocol he recommended (7), the venous blood collected in the tube was centrifuged in a centrifuge device (Medifuge, Silfradent, Italy) at 2700 rpm (approximately 692 g) for 2 min. AFG obtained from the upper part of the tube after centrifugation was collected with the help of an injector and transferred to the metal body. The polymerization was allowed for 15-20 minutes. After polymerization was completed, AFG was applied to the surgical operation area and the operation area was covered with a periodontal pat.
Post Operative Care and Suggestion
Patients were advised to protect the wound area with periodontal pats from trauma, not to consume too hot and too cold foods, and to eat soft foods. It was stated that the pat should be kept in the mouth for 1 week, and if the pat was damaged during this period, they should apply to our clinic immediately. Patients were prescribed paracetamol-containing analgesic (Parol 500 mg) and a mouthwash containing 0.12% chlorhexidine to use three times a day for a week. The patients were only advised not to brush their teeth in the operation area for 1 week. It was stated that he should provide oral hygiene in areas that were not operated. They were advised to use an extra soft toothbrush in the area after the pat was removed.
Surface area determination
Mira-2-tone, a plaque staining agent (GMBH \& Co., Duisburg, Germany), was used to detect wound surface epithelization at baseline, postoperative 7, 14, and 28 days. Standardized photographs were taken from each patient to evaluate the dark stained areas after staining with Mira-2-tone in the gingiva where epithelialization was not completed and wound healing continued. During the photo shoot, the patients were seated upright and facing straight ahead. All photos were taken by a single person on the same camera (Nikon Coolpix 4500, Tokyo, Japan), at the same distance (20 cm) and light values (ISO-800). The photo size was scaled by using a 10 mm Williams periodontal probe during the photo taking. Wound surface epithelization was calculated using Image J software program (National Institutes of Health, USA ImageJ 1.48V) from the photographs obtained. Each measurement step was done by the same researcher (E.B.) each time. The calibration of the person who made the measurements was performed by repeating the wound surface epithelialization area measurement at one-week intervals on the photo images of 10 patients who had undergone gingivectomy and gingivoplasty surgery and were not included in the study. In these two separate evaluations, the calculations were 95% compatible.
Epithelialization test
In order to evaluate the wound surface epithelization during the healing process, 3% H2O2 was applied to the surface of the operation area with the help of an injector. As a result of the decomposition of H2O2 into water and oxygen through the catalase enzyme released by the blood cells present in the wound area, it was evaluated as "epithelization incomplete" if foaming was observed with oxygen formation, and "epithelization completed" if foaming was not observed . H2O2 test was performed at the controls on the 7th, 14th and 28th days after the operation.
Healing index Landry, Turnbull, and Howley (LTH) index, which classified the healing process according to wound surface redness, presence of bleeding, granulation tissue, epithelization, and suppuration (8). The wound healing process with LTH index was performed at the postoperative 7th, 14th and 28th days.
Postoperative pain and aesthetic
VAS was used for postoperative pain and aesthetic evaluation (9). The patient's 7th, 14th He was asked to evaluate the level of pain he felt from 1 to 10 according to the VAS-Pain (1: low pain, 10: severe pain) scale in the control sessions on the 28th and 28th days. In the control session on the 28th day, the patients were asked to evaluate their aesthetic perceptions from 1 to 10 according to the VAS-Aesthetics (1: dissatisfied, 10: very satisfied) scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Split mouth design was used in the study. The chin was divided into lower, upper and right, and left anterior regions. The distribution of the platelet concentrate and control group to be used after gingivectomy and gingivoplasty was randomly decided.
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Other: Control groupAfter gingivectomy and released into the secondary wound healing gingivoplasty group. |
| PRF group | Experimental | Other: PRF groupThe group in which PRF was applied to the wound surface after gingivectomy and gingivoplasty. |
| CGF group | Experimental | Other: CGF groupThe group in which CGF was applied to the wound surface after gingivectomy and gingivoplasty. |
| AFG group | Experimental | Other: AFG groupThe group in which AFG was applied to the wound surface after gingivectomy and gingivoplasty. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are systemically healthy, have chronic inflammatory gingival enlargement in the maxillary and mandibular anterior region, and who do not have attachments and bone loss in clinical and radiographic evaluation.
Key exclusion criteria (1 listed)
- Patients with a history of periodontal treatment in the last 6 months, smokers, those using drugs that may cause gingival enlargement, and pregnant or breastfeeding women were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control groupThe group that did not undergo any procedure after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA) was applied to the wound area. | Other | control group |
| PRF groupThe group in which PRF is applied to the wound area after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA)was applied over the PRF. | Other | PRF group |
| CGF groupThe group in which CGF is applied to the wound area after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA) was applied over the CGF. | Other | CGF group |
| AFG groupThe group in which AFG is applied to the wound area after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA) was applied over the AFG. | Other | AFG group |
Primary outcome
Determination of non-epithelialized areas on the wound surface
Time frame: Postoperative 0, 7, 14 and 28 days, the change of the stained area with the mira-2 tone in the wound surface area was recorded.
Mira-2 tone solution was used to identify non-epithelialized areas on wound surfaces after gingivectomy and gingivoplasty. Mira-2 tone was applied to the wound surfaces and dark dyed areas were calculated as mm2 in Image j program.
Epithelialization test
Time frame: The change in wound surface epithelization was evaluated on the 7th, 14th and 28th days postoperatively.
H2O2 was used to identify non-epithelialized areas. If bubbling is observed after the application of H202 to the wound surface, epithelialization was incomplete, if bubbling was not observed, epithelialization was recorded as completed.
Healing index
Time frame: Wound healing evaluation with LTH index was performed at the postoperative 7th, 14th and 28th day controls.
Landry, Turnbull, Howley (LTH) index, which classified the healing process according to wound surface redness, presence of bleeding, granulation tissue, epithelization, and suppuration, was evaluated.
Postoperative pain
Time frame: Evaluation of VAS-Pain change on postoperative 7th, 14th and 28th days.
VAS was used for postoperative pain assessment. The patients were asked to evaluate the level of pain from 1 to 10 according to the VAS-Pain (1: low pain, 10: severe pain) scale during the control sessions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Background: PubMed 11394395Miranda J, Brunet L, Roset P, Berini L, Farre M, Mendieta C. Prevalence and risk of gingival enlargement in patients treated with nifedipine. J Periodontol. 2001 May;72(5):605-11. doi: 10.1902/jop.2001.72.5.605.
- Background: PubMed 14158464SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.
- Background: PubMed 14121956LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
- Background: PubMed 16504850Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part II: platelet-related biologic features. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e45-50. doi: 10.1016/j.tripleo.2005.07.009. Epub 2006 Jan 10.
- Background: PubMed 21780251Rodella LF, Favero G, Boninsegna R, Buffoli B, Labanca M, Scari G, Sacco L, Batani T, Rezzani R. Growth factors, CD34 positive cells, and fibrin network analysis in concentrated growth factors fraction. Microsc Res Tech. 2011 Aug;74(8):772-7. doi: 10.1002/jemt.20968.
- BackgroundSohn D-S, Huang B, Kim J, Park WE, Park CC. Utilization of autologous concentrated growth factors (CGF) enriched bone graft matrix (Sticky bone) and CGF-enriched fibrin membrane in Implant Dentistry. J Implant Adv Clin Dent. 2015;7:11-29.
- BackgroundLandry RG. Effectiveness of Benzydamine HC1 in the Treatment of Periodontal Post-surgical Patients: Faculty of Dentistry, University of Toronto; 1985.
- BackgroundCrichton N. Visual analogue scale (VAS). J Clin Nurs. 2001;10(5):706-6
- Results publication: PubMed 1527689Miller CS, Damm DD. Incidence of verapamil-induced gingival hyperplasia in a dental population. J Periodontol. 1992 May;63(5):453-6. doi: 10.1902/jop.1992.63.5.453.
- Individual participant dataSharing planned: No. We have other studies using this data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRF group, CGF group and AFG group in people with Wound Heal and Gingival Overgrowth, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of non-epithelialized areas on the wound surface (time frame: Postoperative 0, 7, 14 and 28 days, the change of the stained area with the mira-2 tone in the wound surface area was recorded.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04805463, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.